Duns Number:548239775
Device Description: Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings).3 He Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings).3 Heat,3 Vibration,3 Lumbar. This device complies with part 15 of FCC rules.
Catalog Number
CWT41003
Brand Name
SHARPER IMAGE
Version/Model Number
CHBWO-3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
8d39b356-7d3b-48d0-af83-382724cce19f
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 10, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |